Class 3 Medicines Recall: Chiesi Ltd., Trimbow 87/5/9 mcg pressurised inhalation solution, EL(23)A/36
Chiesi Ltd has informed the MHRA about a potential issue with the batches listed in this notification. This is due to intermittent high results for the uniformity of delivered dose of formoterol fumarate observed during stability testing.
MDR Number: MDR 148-09/23
Company name: Chiesi Ltd.
Product description: Trimbow 87/5/9 mcg pressurised inhalation solution, PLGB 08829/0193 SNOMED Code 34681611000001100
Details of the affected batches:
|
Batch Number |
Expiry Date |
Pack Size |
First Distributed |
|
1165031 |
18/09/2024 |
1 container with 120 actuations |
19/01/2023 |
|
1150215 |
25/12/2023 |
1 container with 120 actuations |
27/04/2022 |
Brief description of problem:
Chiesi Ltd has informed the MHRA about a potential issue with the batches listed in this notification. As a precautionary measure, Chiesi Ltd is recalling the above batches at the pharmacy and wholesale level. This is due to intermittent high results for the uniformity of delivered dose of formoterol fumarate observed during stability testing.
Advice to Healthcare Professionals:
Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Advice to Patients:
No further action is required by patients, these batches are being recalled at the pharmacy and wholesale level as a precautionary measure. Chiesi Ltd has investigated the issue and its medical assessment has shown that the product remains beneficial to patients. Patients should continue to take medicines from these batches as prescribed by your healthcare professional.
Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Company contacts for further information:
For medical information enquiries please contact medinfo.uk@chiesi.com or telephone 0161 488 5555.
For stock control enquiries please contact customerservices.uk@chiesi.com or telephone 0161 488 5521.
To access the full recall: Class 3 Medicines Recall: Chiesi Ltd., Trimbow 87/5/9 mcg pressurised inhalation solution, EL(23)A/36